At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency
In Brief
A Phase 3 clinical trial evaluating IGIV-C 10% and IGSC 20% for Primary Immunodeficiency. Completed, enrolled 53 participants across 25 sites in 2 countries.
Detailed Summary
This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.
Study Details
Timeline
Interventions
IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen
IGSC 20% weekly infusions with dose calculated based on previous IgG regimen